Sentinel System is the U.S. Food and Drug Administration’s (FDA’s) national electronic system to monitor the post-market safety of FDA-regulated medical products (e.g., drugs, vaccines, biologics, and medical devices).
Sentinel maintains access to electronic healthcare data, such as electronic health records (EHR), insurance claims data, and registries, from a number of data partners. The FDA uses this data to monitor the effects of the products they approve/regulate once they go to market.
Specifically, the FDA researchers retrieved healthcare data on how the products have been used to conduct studies. This required the FDA to create a request with Sentinel for defining query parameters, some of which were determined by the FDA and others by Sentinel staff.
However, this was a long and tedious process since there were around 183 parameters to define, and the process involved sharing questions and answers via Excel sheet.
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FDA MyStudies